What is IBS-D? | VIBERZI (eluxadoline) CIV

Irritable Bowel Syndrome with Diarrhea explained

Irritable Bowel Syndrome with Diarrhea, or IBS-D, is not the same as an occasional stomach issue. It is a condition that is long-lasting (chronic), that includes frequent episodes of diarrhea as one of the most common symptoms, along with abdominal pain or discomfort.

The symptoms of IBS-D

Symptoms like abdominal pain and diarrhea are uncomfortable, bothersome, and frustrating. Even when they aren't present, you never know when they might come back.

IBS-D may be more common than you think

While estimates vary, as many as 16 million adults in the United States may suffer from IBS-D. Contrary to popular belief, IBS-D affects as many men as it does women.

51% OF MEN

49% OF WOMEN

Causes of IBS-D

While food or stress can often trigger IBS-D symptoms, there's more to the story. The exact causes of IBS-D are unclear, but experts believe that a few factors may be involved:

1MUSCLES in the gastrointestinal (GI) tract may contract too much

2NERVES in the bowel may not respond as they should

3SIGNALS communicating between the bowel and the brain may be disrupted

If you think you may have IBS-D...

It's important that you talk with your healthcare provider. It may not be an easy subject to bring up, but you can use the Interactive Doctor Discussion Guide to get a personalized report and to help get the conversation started.

Learn more

How IBS-D is diagnosed

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (pancreatitis) has happened most often in people who do not have a gallbladder and can lead to hospitalization. Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI, but can happen after 1 to 2 doses of VIBERZI. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment, but can happen after 1 to 2 doses of VIBERZI.

Stop taking VIBERZI right away and get emergency medical care if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting.

Serious allergic reactions have happened in some people after taking 1 or 2 doses of VIBERZI. Stop taking VIBERZI right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including: swelling of your face, lips, mouth or tongue; shortness of breath or other breathing problems; itching, rash, or hives.
Constipation, including severe constipation that can lead to hospitalization, has happened after taking VIBERZI. Stop taking VIBERZI and call your doctor right away if you develop severe constipation while taking VIBERZI.

Do not take VIBERZI if you:

Do not have a gallbladder
Have or may have had a blockage in your gallbladder or a sphincter of Oddi problem
Have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day
Have had pancreatitis or other pancreas problems, including if you have had or may have had a blockage in your pancreas
Have had an allergic reaction to VIBERZI
Have severe liver problems
Have had long-lasting (chronic) or severe constipation, or problems caused by constipation
Have or may have had a bowel blockage (intestinal obstruction)

Before taking VIBERZI, tell your doctor about all of your medical conditions, including if you have liver problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. If you are taking VIBERZI you should not take medicines that cause constipation, including Lotronex^® (alosetron), anticholinergic medicines, and opioid pain medicines.

The most common side effects of VIBERZI include constipation, nausea, and abdominal pain. Stop taking VIBERZI and call your doctor if you have constipation that is severe. These are not all the possible side effects of VIBERZI. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

For further information, please talk to your healthcare professional.

US-VBZ-230025

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (pancreatitis) has happened most often in people who do not have a gallbladder and can lead to hospitalization. Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI, but can happen after 1 to 2 doses of VIBERZI. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment, but can happen after 1 to 2 doses of VIBERZI.

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (pancreatitis) has happened most often in people who do not have a gallbladder and can lead to hospitalization. Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI, but can happen after 1 to 2 doses of VIBERZI. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment, but can happen after 1 to 2 doses of VIBERZI.

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (pancreatitis) has happened most often in people who do not have a gallbladder and can lead to hospitalization. Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI, but can happen after 1 to 2 doses of VIBERZI. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment, but can happen after 1 to 2 doses of VIBERZI.

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (pancreatitis) has happened most often in people who do not have a gallbladder and can lead to hospitalization. Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI, but can happen after 1 to 2 doses of VIBERZI. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment, but can happen after 1 to 2 doses of VIBERZI.

IMPORTANT RISK INFORMATION

USE

What is VIBERZI?

VIBERZI^® (eluxadoline) is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D).

IMPORTANT RISK INFORMATION

VIBERZI can cause serious side effects, including:

Inflammation of the pancreas (pancreatitis) has happened most often in people who do not have a gallbladder and can lead to hospitalization. Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI, but can happen after 1 to 2 doses of VIBERZI. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI.
A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment, but can happen after 1 to 2 doses of VIBERZI.

Stop taking VIBERZI right away and get emergency medical care if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting.

Serious allergic reactions have happened in some people after taking 1 or 2 doses of VIBERZI. Stop taking VIBERZI right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including: swelling of your face, lips, mouth or tongue; shortness of breath or other breathing problems; itching, rash, or hives.
Constipation, including severe constipation that can lead to hospitalization, has happened after taking VIBERZI. Stop taking VIBERZI and call your doctor right away if you develop severe constipation while taking VIBERZI.

Do not take VIBERZI if you:

Do not have a gallbladder
Have or may have had a blockage in your gallbladder or a sphincter of Oddi problem
Have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day
Have had pancreatitis or other pancreas problems, including if you have had or may have had a blockage in your pancreas
Have had an allergic reaction to VIBERZI
Have severe liver problems
Have had long-lasting (chronic) or severe constipation, or problems caused by constipation
Have or may have had a bowel blockage (intestinal obstruction)

Before taking VIBERZI, tell your doctor about all of your medical conditions, including if you have liver problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. If you are taking VIBERZI you should not take medicines that cause constipation, including Lotronex^® (alosetron), anticholinergic medicines, and opioid pain medicines.

The most common side effects of VIBERZI include constipation, nausea, and abdominal pain. Stop taking VIBERZI and call your doctor if you have constipation that is severe. These are not all the possible side effects of VIBERZI. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

For further information, please talk to your healthcare professional.

US-VBZ-230025